Evidence map›Paper›PMID 33962841›Full record

Trial reportVaccine2021

Safety, immunogenicity, and efficacy of NDV-3A against Staphylococcus aureus colonization: A phase 2 vaccine trial among US Army Infantry trainees.

Eugene V Millar, Jason W Bennett, Burc Barin, Patrick M Carey, Natasha N Law, Caroline E English, Michael M Schwartz, Terrence Cochrane, Michael W Ellis, David R Tribble and 2 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Research progress on T-cell responses inFrontiers in microbiology · 2026
    Pooled it
  2. The evolving landscape ofFrontiers in immunology · 2026
    Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Anti-Heliyon · 2024
    Article
  13. Review
  14. Profiling of serum factors associated withFrontiers in immunology · 2023
    Article
  15. Article
  16. Article
  17. Vaccines against candidiasis: Status, challenges and emerging opportunity.Frontiers in cellular and infection microbiology · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

Eugene V MillarInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, United States; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, United States. Electronic address: emillar@idcrp.org.
Jason W BennettWalter Reed Army Institute of Research, Silver Spring, MD, United States.
Burc BarinThe Emmes Company, Rockville, MD, United States.
Patrick M CareyBenning Martin Army Community Hospital, Fort Benning, GA, United States.
Natasha N LawInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, United States; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, United States; Benning Martin Army Community Hospital, Fort Benning, GA, United States.
Caroline E EnglishInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, United States; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, MD, United States.
Michael M SchwartzNovaDigm Therapeutics, Inc., Grand Forks, ND, United States.
Terrence CochraneNovaDigm Therapeutics, Inc., Grand Forks, ND, United States.
Michael W EllisUniversity of Toledo Medical Center, Toledo, OH, United States.
David R TribbleInfectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University of the Health Sciences, Bethesda, MD, United States.
M Timothy CookeNovaDigm Therapeutics, Inc., Grand Forks, ND, United States.
John P HennesseyNovaDigm Therapeutics, Inc., Grand Forks, ND, United States.
NovaDigm Therapeutics (United States) · USUniformed Services University of the Health Sciences · USCommunity Hospital · USEmmes (United States) · USUniversity of Toledo Medical Center · USWalter Reed Army Institute of Research · US

Funding

NIAID NIH HHS Y01 AI005072
6 · The paper itself

Abstract

backgroundMilitary trainees are at increased risk for Staphylococcus aureus colonization and infection. Disease prevention strategies are needed, but a S. aureus vaccine does not currently exist.

methodsWe enrolled US Army Infantry trainees (Fort Benning, GA) in a phase 2, randomized, double-blind, placebo-controlled trial of NDV-3A, a vaccine containing a recombinant adhesin/invasion protein of Candida albicans that has structural similarity to the S. aureus protein clumping factor A. Study participants received one intramuscular dose of NDV-3A or placebo (adjuvant alone) within 72 h of arrival on base. Longitudinal nasal and oral (throat) swabs were collected throughout the 14-week Infantry training cycle. Safety, immunogenicity, and efficacy of NDV-3A against S. aureus nasal / oral acquisition were the endpoints.

resultsThe NDV-3A candidate had minimal reactogenicity and elicited robust antigen-specific B- and T-cell responses. During the 56-day post-vaccination period, there was no difference in the incidence of S. aureus nasal acquisition between those who were randomized to receive NDV-3A vs. placebo (25.6% vs. 29.1%; vaccine efficacy [VE]: 12.1%; p = 0.31). In time-to-event analysis, there was no difference between study groups with respect to the S. aureus colonization-free interval (VE: 13%; p = 0.29). Similarly, the efficacy of NDV-3A against S. aureus oral acquisition was poor (VE: 2.4%; p = 0.52).

conclusionsA single dose of NDV-3A did not prevent nasal nor oral acquisition of S. aureus in a population of military trainees at high risk for colonization.

Indexed as

Military PersonnelStaphylococcal InfectionsStaphylococcal VaccinesVaccinesHumansImmunogenicity, VaccineStaphylococcus aureusStaphylococcal VaccinesVaccinesColonizationMilitary traineesMRSAStaphylococcus aureusVaccine

Identifiers

PMID33962841
PMCPMC10430023
OpenAlexW3158258934

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.